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Risk-based monitoring in clinical trials involves targeted monitoring that may include 100% source data verification for specified critical data points and partial source data verification of other data.
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The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data.
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Certification is recognized throughout the clinical research field as a sign of professional competency and knowledge of clinical development in the pharmaceutical industry
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Proper site management by the Sponsor and/or CRO is an essential element of clinical trial execution and in ensuring trial success. An appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects while ensuring regulatory compliance, protocol adherence, the protection of subjects’ rights, subject safety, and overall management of screened and enrolled subjects.
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Today’s clinical development is more patient-centric – focusing not only on treating the patient’s disease or dysfunction but also on the patient’s experience of, and desired outcomes for, treatment.